EndoStim Gets CE Mark Approval for Acid Reflux Treatment
8/20/2012 8:16:00 AM
THE HAGUE, Netherlands, Aug. 16, 2012 /PRNewswire/ -- EndoStim B.V. announced today CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD).
The EndoStim system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle which is the underlying cause of gastro-esophageal reflux disease (GERD) or acid reflux. EndoStim's device, implanted through a minimally-invasive laparoscopic procedure, is intended to treat acid reflux and eliminate the need for daily PPI medication. In clinical trials the treatment was able to significantly reduce acid exposure and related symptoms of heartburn and regurgitation without causing any gastrointestinal side effects seen with other anti-reflux procedures.
Bevil Hogg, President and CEO of EndoStim, stated, "EndoStim is very excited to offer a truly revolutionary treatment to patients with severe GERD -- one that is designed to normalize esophageal function. EndoStim is working closely with leading GERD experts throughout the world to develop 'Centers of Excellence' offering EndoStim treatment for the millions of GERD sufferers worldwide."
Virender K Sharma MD, Chief Medical Officer of EndoStim and Director of the Arizona Center for Digestive Health, adds, "EndoStim LES stimulation therapy is a result of years of research and development with leading researchers in esophageal diseases in the US and clinical investigators in Europe and South America. EndoStim's long-term clinical data strongly supports the efficacy and safety of its therapy in patients with severe GERD."
Clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77% achieved normalization or greater than 50% reduction in abnormal esophageal acid exposure.
EndoStim LES stimulation therapy has shown both daytime and nighttime improvement in heartburn symptoms and regurgitation. The treatment is also unique in its ability to be personalized to individual patient lifestyle, diet and preferences. According to Dr. Joel Richter, Professor of Medicine and Director of the Division of Digestive Diseases and Nutrition at the University of South Florida, "What separates EndoStim LES stimulation technology from all previous GERD technologies is its ability to correct GERD pathophysiology and normalize or improve esophageal acid exposure. Safety and lack of side effects with this technology makes it an attractive option for patients looking for alternatives to traditional medical therapy."
Dr. Leonardo Rodriguez, the lead investigator for the CE Mark trial conducted in Santiago, Chile, says, "I believe that EndoStim LES stimulation therapy is the ideal treatment option for patients with severe GERD who are unhappy with their medical therapy or want freedom from life-long dependence on medications. I am very impressed with the clinical results and look forward to offering EndoStim therapy to my GERD patients."
EndoStim is continuing trials in key centers across South America, Europe, and Asia. Prof. Peter D Siersema, Professor of Medicine, Director of Gastroenterology at University Medical Center, Utrecht, The Netherlands and a principal investigator in the ongoing EndoStim international multicenter trial commented that, "We are excited to be among the first sites in Europe to offer the EndoStim LES stimulation therapy to our patients. The EndoStim technology has the potential to change the way we manage GERD. With its ability to personalize treatment to an individual patient's condition, and with its excellent safety profile, EndoStim therapy could become the ideal option for reflux patients unsatisfied or unhappy with daily medications."
EndoStim has begun enrolling a commercial registry study worldwide and is planning for a US study to begin in late 2013.
About Reflux Disease
Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when the weakness in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal irritation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett esophagus and esophageal cancer. Millions of people continue to suffer from bothersome GERD symptoms despite maximal medical therapy.
EndoStim is a venture-backed medical device company based in The Hague, The Netherlands, and St. Louis, Missouri, focused on developing innovative active implantable devices. Key investors include Santé Ventures (Austin, TX), Prolog Ventures (St. Louis, MO), Voyent Partners (Brentwood, TN) and Vectis Healthcare & Life Sciences Fund II (St. Louis, MO), along with many individual investors. For more information and news about EndoStim, please visit www.endostim.com.